Chromatographic, Phospholipids
The Chromatographic, Phospholipids test is a clinical chemistry diagnostic device that uses chromatographic separation techniques to measure and fractionate phospholipids in biological specimens such as serum or plasma. Assessment of phospholipid profiles assists in evaluating lipid metabolism and conditions related to hepatic function and cardiovascular disease risk. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JNT and is regulated under 21 CFR 862.1575, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JNT
- Device Class
- FDA class 1
- Regulation Number
- 862.1575
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K922792 | ZITHROMAX | Jul 30, 1992 | Substantially Equivalent | Difco Laboratories, Inc. |
| K914040 | PHOSPHOLIPID REAGENT SET | Oct 30, 1991 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K792349 | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. | Mar 12, 1980 | Substantially Equivalent | Pfizer, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.